MAUDE Adverse Event Report: Symatese Evolysse Form; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	EVO-FRM-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pain (1994); Subcutaneous Nodule (4548); Swelling/ Edema (4577)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported being injected with evolysse form in the lips during an onsite training session at her place of employment on (b)(6) 2026.After an unspecified period of time the patient experienced persistent, hard nodules throughout her lips.The patient reported undergoing multiple treatments to dissolve the product with 21 vials of hylenex.As of (b)(6) 2026, the patient reported the product is still not fully dissolved.
Additional Manufacturer Narrative
The filler was injected into the patient and is not available for return.The batch release form was reviewed, and the device met all specifications prior to release.The product was used off label in the lip region.We cannot rule out that this may have contributed to the reported event.(b)(4).

• Brand Name: Evolysse Form
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Symatese; zi les troques; chapnost, auvergne-rhone-alpes 69630 ; FR 69630
• MDR Report Key: 50075174
• Report Number: 3015260155-2026-00011
• Device Sequence Number: 10253297
• Product Code: LMH
• UDI-Device Identifier: 03760172161264
• UDI-Public: (01)03760172161264(17)270228(10)S2251070178
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026
• Report Date (Section F): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EVO-FRM-01
• Device Lot Number: S2250760084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/03/2026
• Event Location: Other
• Date Report to Manufacturer: 08/17/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 08/17/2026